EU MDR (Medical Device Regulation)

EU MDR (Regulation (EU) 2017/745) raised clinical evidence, technical documentation, and post-market surveillance expectations for medical devices sold in Europe. Classification, GSPR conformity, clinical evaluation reports, PMS/PMCF plans, and Notified Body review capacity all affect timelines. MDR is a lifecycle framework, not a one-time filing event, and legacy devices often need substantial remediation before continued placement on the market under the new rules.

Viltis helps manufacturers and sponsors plan MDR remediation and ongoing conformity work. We support gap assessments against Annexes and MDCG guidance, technical file upgrades, clinical evaluation strategy, and coordination with your chosen Notified Body. Viltis does not act as a Notified Body and does not issue CE certificates; we prepare you for assessments those bodies perform and help you respond to questions without reinventing the file under clock-stop pressure.

Many programs also need to reconcile MDR expectations with FDA device strategy. Clinical evidence depth, labeling, and post-market systems often differ. We help you sequence work so U.S. and EU packages share what they can and diverge only where the rules require it, reducing duplicate studies and conflicting claims across IFUs, labels, and marketing materials used in both regions.

Notified Body capacity and clock-stops are real schedule risks. Realistic MDR plans treat those constraints as planning inputs, not surprises discovered after a submission slot is already booked and a launch date has been promised to commercial leadership. For software-containing devices and SaMD, we help you connect MDR clinical evaluation and risk management expectations with the software lifecycle evidence reviewers expect, so cybersecurity and usability files are not left as last-minute annexes.

EU MDR consulting typically includes

• MDR gap assessments for legacy and new devices
• Technical documentation and clinical evaluation support
• PMS, PMCF, and vigilance process alignment
• Classification and conformity route advice for planning
• Notified Body interaction preparation (sponsor-side)
• Remediation roadmaps tied to launch or continued placement priorities
• Coordination with FDA 510(k)/De Novo/PMA evidence plans

MDR success depends on honest gap closure and sustained post-market discipline. Viltis brings device regulatory experience to help you plan that work with realistic timelines, clear ownership, and documentation that holds up in review. Treat MDR as continuous conformity work and the Notified Body review becomes a checkpoint, not a scramble.